Access Device And System For A Heart Including A Cardiac Assist Unit

ABSTRACT

An access device for a heart chamber, a removable hemostatic valve unit, and a system including a cardiac assist unit are disclosed. In examples, the access device) includes an apical base plate and a sealing unit configured to provide a separation of a wet zone from a heart chamber and a dry zone with a gaseous environment outside of said heart chamber inside a patient body at the same time.

RELATED APPLICATIONS

This application is a bypass continuation of and claims priority toInternational Patent Application No. PCT/EP2020/088064, InternationalFiling Date Dec. 30, 2020, entitled An Access Device For A Heart, ARemovable Hemostatic Valve Unit, And A System Including A Cardiac AssistUnit, which claims priority to U.S. application Ser. No. 16/990,903filed Aug. 11, 2020 entitled An Access Device For A Heart, A RemovableHemostatic Valve Unit, And A System Including A Cardiac Assist Unit,which is a bypass continuation of and claims priority to InternationalPatent Application No. PCT/EP2019/087182, International Filing Date Dec.30, 2019, entitled An Access Device For A Heart, A Removable HemostaticValve Unit, And A System And A Method Of Creating A Transapical PassageOn A Beating Heart, all of which are hereby incorporated herein byreference in their entireties.

BACKGROUND OF THE INVENTION Field of the Invention

This disclosure pertains in general to the field of cardiac medicaldevices. More particularly the disclosure relates to access devices fora heart, in particular transapical access devices being transapicalports to and from a heart's chambers. Also, the disclosure relates tohemostatic valve units, in particular hemostatic valve units fordelivery of medical devices via a cardiac apex to a heart, and even moreparticularly to such hemostatic valve units with variable orifices andpreferably removable from the heart after use. In addition, thedisclosure relates to medical procedures, methods and systems of and forcreating a transapical passage on a beating heart. Moreover, thedisclosure relates to medical systems including cardiac assist units tobe transapically implanted. Furthermore, the disclosure relates toapical base plates including a connection interface. In addition, thedisclosure relates to medical procedures, methods and systems of and fortransapically implanting a cardiac assist system.

Description of Prior Art

This section is intended to introduce the reader to various aspects ofart that may be related to various aspects of the present disclosure,which are described and/or claimed below. This discussion is believed tobe helpful in providing the reader with background information tofacilitate a better understanding of the various aspects of the presentdisclosure. Accordingly, it should be understood that these statementsare to be read in this light, and not as admissions of prior art.

In international patent publication number WO2009100198A2, transapicalheart ports, methods for making transapical heart ports, and methods forusing transapical heart ports are provided. However, these heart portsmay be further improved.

In British patent specification number GB1514019 a hemostatic valve witha fluid pressure controllable cross section is disclosed. However, thesehemostatic valves may be further improved.

In international patent publication WO 2018/167059 A1, a transapicalheart port is disclosed. The heart port is for use during cardiacsurgery to access the interior of a heart via its apex. The heart portis removed after the surgical procedures are performed (page 8 lines 9to 10). During the procedure it has a hemostatic valve attached to itshousing, more precisely it is screwed onto the proximal part of theport. The valve is not disclosed as removable during use. The valvecannot be removed, i.e. disassembled, from the port during use as thiswould cause undesired blood loss. The port is also not disclosedproviding a dry zone in the patient when permanently implanted (i.e.surgery is ended, and the patient body is closed again) as it is removedfrom the patient.

In international patent publication WO 2011/017440 A1, organ ports aredisclosed, such as transapical heart ports and methods and materials forimplanting such organ ports. The ports are for use during medicalsurgical procedures and can include a hemostatic valve attached to ahousing of such port and located within a channel for instance to reduceblood loss from a heart through the channel. However, such ports are notdisclosed providing a dry zone in the patient when permanently implanted(i.e. surgery is ended, and the patient body is closed again).

In United States Patent Application Publication US 2016/0081715 A1, asurgical access device is disclosed for introduction of surgicalinstrumentation into a patient's body. The device includes a lateralmoving seal cooperating with a bellows. The bellows is arranged betweenan inner and an outer seal housing and establishes a biasingrelationship with the seal. The device is not suited for permanentimplantation, e.g. for use with a cardiac assist device. It is also notsuited as a cardiac transapical heart port.

A similar seal assembly with a bellows is disclosed in U.S. Pat. No.5,492,304. A bellows allows reduction of the overall axial dimension ofthe seal assembly. However, the device is not suited for permanentimplantation, e.g. for use with a cardiac assist device. It is also notsuited as a cardiac transapical heart port.

For instance, it would be desired to provide a permanent separation of awet zone from a heart chamber and a dry zone with a gaseous environmentoutside of said heart chamber inside a closed patient body at the sametime.

A transapical access device is desired that prevents blood leakage whileworking on a beating heart and which allows for attachment of otherunits than hemostatic valves, and in particular, other units that have alarger dimension than an opening of a through channel in a hemostaticvalve.

It is also desired to be able to transfer a movement longitudinallyacross the apex without bleeding and easy installation of a sealing unitat the apex.

Another desired property is that access to a heart chamber at a laterpoint is facilitated, e.g. for repair or replacement of componentsinstalled inside the heart.

SUMMARY OF THE INVENTION

Embodiments of the present disclosure preferably seek to mitigate,alleviate or eliminate one or more deficiencies, disadvantages or issuesin the art, such as the above-identified, singly or in any combinationby providing devices, systems and methods according to the appendedpatent claims.

The present invention is defined by the appended claims only, inparticular by the scope of appended independent claim(s). Reference(s)to “embodiments” throughout the description which are not under thescope of the appended claims merely represents possible exemplaryexecutions and are therefore not part of the present invention.

According to aspects of the disclosure, access devices for a heart,removable hemostatic valve units, a system and a method of creating atransapical passage on a beating heart, and a method of transapicallyimplanting a cardiac assist system are provided, medical systemsincluding cardiac assist units to be transapically implanted, and apicalbase plates, are provided herein. An apical base plate is a plate forattachment to an apex region of a heart.

As mentioned above, this document relates to medical devices. Forexample, this document provides transapical heart ports and methods forusing transapical heart ports. The transapical heart ports providedherein can be inserted and secured to the apex of a beating heart toprovide secure access to the inside or interior of the heart. Thedevices provided herein provide access to the inside of the heart viathe apex without blood loss around instruments being introduced into theheart. The transapical heart ports provided herein can be used duringsurgeries where the patient's heart remains beating. The transapicalheart ports provided herein can be used for inserting instruments ofvarious types into the heart. For example, annuloplasty rings,artificial valves, valve clips, cardiac assist components, can beinserted into the heart, such as by using an exemplary delivery system 7shown in FIGS. 20A and 20B.

In examples, the access device includes an apical base plate and asealing unit 3 configured to provide a separation of a wet zone 30 froma heart chamber 20 and a dry zone 32 with a “gaseous environment” suchas outside of said heart chamber inside a patient body at the same time,as defined below.

The sealing unit 3 is not included in a hemostatic valve, or part of ahemostatic valve but rather a separate entity, as elucidated herein.

In some cases, a transapical heart port provided herein can be insertedat the apex of the heart, for example, using an open surgical incisionor percutaneously. In some cases, a transapical heart port itself canprovide secure access such that instruments can be exchanged during theintracavitary surgery without concern that one would lose control of theapex of the heart (e.g., to prevent bleeding through or around thetransapical heart port and to maintain blood pressure in the patient).

The transapical heart port provided herein is intended to remainpermanently implanted in place after completion of the operation beingperformed on the heart. A sealed access to the interior of the heart isprovided in some configurations.

The access device 1 has for instance in examples a first, open patient(body) configuration. An open patient configuration means that thepatient body is opened for a surgical procedure, often by a sectionthrough the patient skin, and during the surgical procedure—in contrastto a closed patient (body) configuration. In the example of the openpatient body configuration, a removable hemostatic valve unit 2 isremovably attached to a proximal side of said apical base plate 100. Inthe first configuration, examples include that only the hemostatic valveunit 2 is mated with the apical base 100.

The access device 1 has for instance in examples a second, closedpatient (body) configuration, A closed patient (body) configurationmeans that the patient body is closed after conclusion of the surgicalprocedure. In the closed patient configuration, the sealing unit 3, thatoptionally includes a feed-through port 320, is preferably distallyattached to said base plate 100 for providing the separation of wet anddry zones. In the first configuration, examples include that the sealingunit 3 is mated with the apical base 100.

In a third configuration of the access device 1, both the hemostaticvalve unit 2 and the sealing unit 3 are mated to the apical base 100.This third configuration is also an open patient (body) configuration. Atransition configuration from the first to the second configuration mayinclude the sealing unit 3 inserted into the hemostatic valve unit 2 fordelivery to the apical base plate 100.

The access device, including the apical base plate (100) includespreferably a tubular through port 120 adapted to be arranged acrosscardiac tissue.

According to one aspect of the disclosure, access devices for a heartare provided. The devices include an apical base plate that has atubular through port to be arranged across cardiac tissue. “Across”means in the present context through cardiac tissue and between aninside and an outside of the heart. The cardiac tissue at the apex isthus provided with a tubular port extending from the outside of theheart tissue to the inside of a heart chamber at the apex region of theheart. This port can be to/from the left or the right chamber.

The access device has a first configuration wherein a removablehemostatic valve unit is attached to the base plate. The port is thusopen for fluid communication and is closable to prevent bleeding,controllable by the valve.

Advantages of a removable hemostatic valve include for instance one ormore of the following technical effects. It prevents blood leakage whileworking on a beating heart. Being removable, it allows for attachment ofother units than hemostatic valves—instead of the valve but also inaddition to the valve before removal of the valve. Other units can havea larger dimension than an opening to a through channel in thehemostatic valve, in particular if the valve housing is provided assplittable for providing a peel off valve. It may be a re-usable valve.It may be re-attached if needed. In particular if the re-attached valvehousing is provided as splittable for providing a peel on valve. Itprovides for attachment of a driving unit in a transition configurationof a drive unit, valve, base plate, sealing unit. It provides fortemporary sealing of a cardiac access channel, e.g. for installingexamples of a permanent sealing unit 3 that is adapted to remainimplanted. It provides for creation of a wet dry zone separation. Are-attachable hemostatic valve, e.g. in the form of a peel on valve,provides the possibility to exchange, replace, reposition, repair,and/or improve single and/or multiple components or entire modules suchas a bellows 310 or products such as a drive unit of a cardiac supportsystem. An example of a removable and re-attachable hemostatic valve isseen in FIGS. 25A to 25E. In FIG. 25A or 25D examples is a hemostaticvalve are illustrated in assembled state and FIGS. 25B, 25C and 25E showexamples of a hemostatic valve illustrated in dissembled state,respectively. Parts 202, 204 illustrate some of the splittable parts ofthe hemostatic valve.

A “wet dry zone” as used in this disclosure includes a separation of awet zone, i.e. containing blood, in a heart chamber, from a dry zone,i.e. a gaseous or in particular air containing environment, such asoutside of the heart chamber, but in any case inside an intact humanbody, at the same time.

The gaseous environment may for instance be provided outside of theheart chamber, see an example illustrated in FIG. 23 with a gaseousenvironment inside the drive unit 6.

Additionally, or alternatively, the gaseous environment may be providedinside the heart chamber, sealed from the wet zone, see e.g. FIG. 11C orFIG. 23 , where the sealing unit 3 has a gaseous environment in itsinterior securely sealed from the blood in the chamber, i.e. away fromthe wet zone.

Additionally, or alternatively, the gaseous environment may be providedinside the transapical hole, see e.g. FIG. 11C or FIG. 23 , where thesealing unit 3 provides for a gaseous environment inside the transapicalhole.

Alternatively, or in addition, the gaseous environment may at leastpartly contain a liquid to provide a “gaseous” environment containing amedium different than blood, such as a biocompatible lubricant mediume.g. for mechanical parts to enhance operational life, and/or aprotective gas, or a mixture thereof, such as aerosol particles in gas.As long as the “gaseous” environment of the dry zone is securely sealedinside the patient body from the wet zone containing blood, it is a“gaseous” environment as used in this disclosure.

The wet dry zone is thus providable during permanent implantation of amedical device, such as an apical base plate, in a closed patient'sbody.

The access device has a second configuration wherein a sealing unit witha feed-through port 320 is attached to the base plate. The feed throughport is provided with separation of the wet zone and dry zone. Amembrane, like including a silicone (or other synthetic material likePVC, Polyurethane, etc.) bellow is provided for separating the wet zonefrom the dry zone. The membrane may consist of more than one membrane orbellow in order to create a membrane in membrane solution or bellow inbellow solution. The different bellows, in a bellow in bellow solution,may consist of different materials. The different materials may havedifferent properties, like different permeability of particles. In thisway, a more efficient “total” membrane may be costumed and/or created.The different bellows may also consist of the same material, e.g. inorder to create an extra safety if one bellow may break and/or leak.This may prevent gas leakage from dry zone into blood stream. Thefeed-through port means that devices may cross the dry zone to/from thewet zone. The feed through port 320 is for instance provided at thedistal end portion of the sealing unit 3. A sealing member, like anO-ring, 326 may be provided to provide sealing at the feed through port.Alternatively, the feed through port may be without a sealing member buta closed membrane, e.g. for magnetic couplings as shown in FIGS. 24A,24B and 24C. In this second configuration, the port is closed for fluidcommunication by means of the sealing unit. A feed-through port, e.g.for medical devices is however provided in this configuration. Thesealing unit provides for the wet/dry zone separation.

Some examples of the sealing unit 3 provide for a possible movement ofmechanical parts via/across the apex and a separation of a wet zone,e.g. blood in heart chamber, and a dry zone, i.e. gaseous/airenvironment outside of heart chamber, at the same time without leakageof blood or gas over the separation by e.g. a membrane for instanceincluding a bellows 310. Such a sealing unit 3 may include a detainingunit 330 to provide a detainment of blood and/or gas in order to delayand/or prevent an exchange of blood or gas over the separation e.g. incase of a membrane malfunction. In examples, the detaining unit maydelay and/or prevent a leakage of blood or gas over a membrane if forinstance a bellows 310 would break or malfunction. In examples, thedetaining unit is a sponge, or consists of sponge-like material, whichallows for slow or inhibited leakage of gas into blood, or vice versa.In other examples, the detaining unit may include a three-dimensionalmaze that allows for gas to freely pass through but can provide a delayand/or entirely prevent blood from passing through the maze. Thedetaining unit may be positioned inside the sealing unit 3. Forinstance, the interior channel of the bellows 310 may be provided withthe detaining unit. Alternatively, or in addition, the detaining unitmay be provided in the top of the sealing unit 3 (when assembledpositioned in tubular through port 120), see e.g. in the interior spaceof the tubular through port 120 inside sealing unit 3 such asillustrated in FIG. 22B. A detaining unit consisting of a maze wouldprovide a detainment of blood causing a detainment of gas and thus woulddelay and/or prevent an exchange of blood or gas over the separation. Inother examples, the detaining unit may provide a controlled leakageand/or dissolvement of gas in blood, or vice versa, due to the costumeddesign of the detaining unit. The detaining unit may be constructed as adiffusor for spreading gas into liquid in a controlled way, e.g. inorder to dissolve in blood. The detainment unit improves patient safetyas it avoids or slows down potential gas leakage into the blood streamof the patient, or as it avoids, or slows down potential blood leakageinto the device. In this context it should be noted that small amountsof gas released over time are either not harmful or can be dissolved inthe blood, which is not critical for the patient. On the other hand, thesame amount of gas released instantaneously could be life threatening,but this is avoided by the detaining unit.

A sealing unit with bellows allows for a, e.g. longitudinal and/oraxial, movement of medical device parts relative each other, e.g. forpiston or rods' movements. A sealing unit with bellows allows inaddition or alternatively for radial movement of device parts relativeeach other, in particular from outside the heart to the inside of theheart, while the wet/dry separation is maintained.

The sealing unit provides in an advantageous manner a separation of awet zone from a dry zone.

The sealing unit may be provided with a magnetic coupling, as shown inan example in FIGS. 24A, 24B and 24C. A magnetic coupling provides foreasy assembly of components of a system to be implanted, and/or easydetachment of components such as for replacement, addition, removal orrepair of such components. It provides for a total sealing of the feedthrough port without a through channel.

According to another aspect of the disclosure, a hemostatic valve unitis provided. The valve unit has a housing with a distal end and aproximal end. It is removably connectable at the distal end to an apicalbase plate of an access device for a heart. The valve unit includes apneumatic valve in a through channel of the valve unit between thedistal end and the proximal end. The valve is re-attachable if needed,e.g. for later access such as for replacing/repairing components of acardiac assist system. Advantages of a removable valve are alreadydescribed above and also apply for this aspect.

According to yet another aspect of the disclosure, applicator tools areprovided for creating a transapical passage on a beating heart. Theapplicator tool (in short herein referred to as the “tool”) includes inexamples a harpoon insertable through a tube of the applicator tool. Theharpoon has a distal tip for penetrating cardiac tissue at an apex of aheart. The tube has a sharpened edge at a distal end for cutting thecardiac tissue at the apex. The harpoon has an expandable flange forpreventing withdrawal of the harpoon through the cardiac tissue, inparticular while cutting with the tube and providing a clean cut becauseit provides in use a counterforce against the tube's cutting edge,wherein the flange is configured to keep the cut cardiac tissue withinthe tube.

Some examples of the disclosure provide for applicator tools withimproved patient safety as embolization of cut cardiac tissue isprevented. The tissue that is cut is safely kept in the tube with theharpoon flanges or wire mesh holding back the tissue in the tube.Complications like stroke are minimized or avoided by such examples ofapplicator tools for creating a transapical passage on a beating heart,which is a particular challenge because of the heart movements andrelated difficulties to contain cut tissue and prevent it from beingentrained with the blood flow of the beating heart for instance. Thetool is advantageous as it provides that leakage of blood from thechamber is prevented when creating a transapical passage. Thepenetration through the cardiac tissue to the chamber, e.g. at the apex,is recognized by the operator as complete, e.g. by an integrated bloodindicator 490. Also, an access device is deliverable over the same toolpreparing the puncture, thus a shortened and more safe medical procedureis provided. The tool provides a reproducible desired hole size. Theapplicator tool avoids undesired, e.g. too large or small cutting oftransapical holes. The applicator tool provides for a reproduciblemedical procedure, in a pre-configured sequence assisting medicalpersonal during implantation. The tool provides for a safe medicalprocedure with reduced overall patient risk compared to manual cuttingof a hole in cardiac muscle tissue with a scalpel.

According to yet another aspect of the disclosure, applicator tools forcreating a transapical passage include a harpoon insertable through aco-axial dilator of the tool. The harpoon has a distal tip forpenetrating cardiac tissue at an apex of a heart. The dilator providesdilating of the cardiac tissue. The applicator tool furthermore includesan access device for a heart that has a tubular through port to bearranged across the cardiac tissue when advanced over the dilator.

The applicator tool has the same advantages as mentioned above for theprevious tool, except tissue that is cut is not kept in the tube withthe harpoon flanges or wire mesh holding back the tissue in the tube.

According to yet another aspect of the disclosure, a transapical accesssystem for creating a transapical passage on a beating heart isprovided. The system includes an access device for a heart according tothe afore described aspect of the disclosure. In addition, the systemincludes an applicator tool for creating a transapical passage anddelivering the access device to an apex of the heart, as described aboveaccording to the afore described aspects of the disclosure. The systemmay provide all or some of the advantages and technical effects of itscomponents described herein.

According to yet another aspect of the disclosure a medical systemincludes a cardiac assist unit to be transapically implanted. Thecardiac assist unit is attachable to a sealed access device. The accessdevice provides for the wet/dry zone separation inside the body. Theassist unit is arranged on the dry side. Assembly of the system andimplantation is advantageously easy as bleeding is avoided upon andafter implantation. As blood cannot enter the assist device, it can beimplanted inside the body. Mechanical parts of the assist devicearranged in the dry zone are protected from blood, leading to increasedtime of life, reduced risk for complications, like blood clotting,infections etc. Electronics inside the assist device is protected fromshort circuits when arranged in the dry zone.

According to yet another aspect of the disclosure, a sealed apical baseplate is provided, which includes a connection interface for matinglyengagement of multiple medical devices that in turn have matingconnection interfaces for connection to the apical base plate,respectively.

The connection interface may include a freely rotatable connection of asystem including a medical device relative the apical base plate. Freelyrotatable may include three-dimensional movement around a pivot point.Free rotation provides for flexibility for instance when positioning amedical (assist) device during implantation. The free rotation allowsfor movement of parts relative each other when implanted after ingrowth.This avoids injuries like necrosis e.g. in connecting tissue at theimplantation site. Mounting spikes of the base plate are optional andomitted for instance in a free rotation design as these mounting spikescould otherwise prevent the free rotation. The free rotation avoidstension in the implanted system since the devices of the systemconnected at the connection interface will continuously strive towards astress-free position. The system has thus a long lifetime and is highlybiologically compatible.

According to yet another aspect of the disclosure, a method of creatinga transapical passage on a beating heart is provided. The method ormedical procedure include determining a position on an apex region forcreating a transapical passage. This may for instance be done imagingmodality providing suitable image data for processing and analysis, e.g.CT based, MR based, Ultrasonic based. Alternatively, or in addition, theposition may be determined by tactile sensing and/or visual inspectionof the heart, e.g. during surgery. The method further includes creatinga transapical hole at the determined apex region through cardiac tissue,such as by punching and/or cutting through the tissue. The methodfurther includes delivering an access device, such as an apical baseplate, which has a tubular through port to the transapical hole. Themethod further includes attaching a flange unit of the access device toan outside of the heart, and removably connecting a hemostatic valveunit to the access device. The method provides for an advantageouscreation of a wet zone/dry zone separation inside a body. The methodprovides for ease of access to a heart chamber for various proceduresand/or medical devices. The method and related devices provide for safecreation of a passage through cardiac tissue, e.g. a transapicalpassage, while preventing embolies of tissue removed for the passage,e.g. of a punched hole through cardiac tissue. The method and useddevices effectively prevent bleeding. The method and used devicesprovide for reproducible hole sizes. The method and used devices avoidtoo large cutting of transapical holes, which is an issue difficult toremedy. A reproducible medical procedure is provided as the method needsto be done in a pre-configured sequence, as given by the devices used,assisting medical personal during implantation. Overall, the methodprovides for a safe medical procedure with reduced risk for patients.

According to yet another aspect of the disclosure, a method oftransapically implanting a medical device like a cardiac assist systemon a beating heart is provided. The method or medical procedure includesattaching the medical device like a cardiac assist unit to a sealedaccess device. The medical device like an assist unit is removablyattached to the sealed access device, which has a number of advantages.For instance, removable devices provide for extended life of the entireimplanted system with replaceable and/or repairable units. The implantedsystem may easily be updated with improved or enhanced future devices.Repeated access to heart chambers is provided through a permanentlyimplanted access device. Also, the removable medical device can beremoved when no longer required (patient treatment successful)

Further embodiments are defined in the dependent claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-B illustrate an example of access devices for a heart;

FIG. 2 is a top view of a template 190 for positioning an access device1;

FIGS. 3A-B illustrate a hemostatic valve unit 2;

FIGS. 4A-B illustrate inflatable balloon configurations of hemostaticvalve units;

FIGS. 5A-C illustrate a first configuration of the access device 1;

FIG. 6 illustrates an implanted access device 1 in a firstconfiguration;

FIGS. 7A-B illustrate a sealing unit for mounting in an access device 1for providing a second configuration;

FIGS. 8A-B and 9A-B illustrate a transition from a first configurationto a second configuration of an access device 1;

FIGS. 10A-B and 11A-B illustrate a second configuration of the accessdevice 1, in particular an example of a sealed access device 1, whichincludes a connection interface 110 for matingly engagement of multiplemedical devices;

FIG. 11C illustrates an implanted access device in a secondconfiguration;

FIGS. 12A-B illustrate an example of an applicator tool for creating atransapical passage on a beating heart with a tube that for instance hasa sharpened edge at an end thereof, while a grip with open lock isshown;

FIGS. 13A-D illustrate a harpoon needle, rod with a retaining unit inform of expandable barbs and a punch tube with sharp end edge assemblyin different configurations;

FIGS. 14A-C illustrate creation of a transapical puncture in a heartwith an applicator tool shown in FIGS. 12 and 13 ;

FIGS. 15 and 16 illustrate a detail of the applicator tool;

FIG. 17 illustrates the applicator tool in a configuration where thetransapical puncture is made and a tissue plug is safely contained inthe tube of the tool;

FIG. 18 illustrates an applicator tool with a dilator;

FIGS. 19A-B illustrate an example of a transapical access system 5assembled and ready for use including an applicator tool, an accessdevice for a heart and a hemostatic valve;

FIGS. 20A-B illustrate a delivery device for a medical device to theinterior of the heart, insertable through a hemostatic valve and anaccess device in a first configuration;

FIG. 21 illustrates the delivery device of FIGS. 20A-B transapicallyinserted into a heart through a hemostatic valve and an apical accessdevice in a first configuration as described herein;

FIGS. 22A-B illustrate an example of a medical system including acardiac assist unit to be transapically implanted attachable to a sealedapical base plate;

FIG. 23 illustrates an implanted access device with sealed apical baseplate and attached cardiac assist unit;

FIGS. 24A-C illustrate an alternative sealing unit with a magneticcoupling;

FIGS. 25A-E illustrate a splittable hemostatic valve unit;

FIG. 26 illustrate steps of an example of a method of creating atransapical passage on a beating heart;

FIG. 27 illustrate steps of an example of a method of transapicallyimplanting a cardiac assist system;

FIG. 28A-F illustrate examples of an apical base plate.

DETAILED DESCRIPTION

Specific examples of the disclosure will now be described with referenceto the accompanying drawings. Inventions comprised herein may, however,be embodied in many different forms and should not be construed aslimited to the examples set forth herein; rather, these examples areprovided so that this disclosure will be thorough and complete, and willfully convey the scope of an invention to those skilled in the art. Theterminology used in the detailed description of the examples illustratedin the accompanying drawings is not intended to be limiting of aninvention. In the drawings, like numbers refer to like elements.

Now turning to the figures, FIGS. 1A and 1B illustrate an example of anaccess device 1 for a heart, wherein FIGS. 5 and 6 illustrate a firstconfiguration of the access device; and FIGS. 10 and 11 illustrate asecond configuration of the access device 1.

The access device 1 include an apical base plate 100 that has a tubularthrough port 120 to be arranged across cardiac tissue at an apex 12 of aheart 10. The cardiac tissue at the apex 12 is thus provided with atubular through port 120 extending from the outside 14 of the hearttissue to the inside 15 of a heart chamber at the apex region of theheart 10. This port can be to/from the left or the right chamber of theheart 10, depending on the position at the apex region.

Mounting spikes 150, 151 are provided on the access device for receivingmating apertures or recesses 250, 251 of e.g. a valve unit 2 or acardiac assist drive unit 6. If having different shape of mating pairsof spikes and apertures, this provides for a rotational correct mountingof units to the access device.

Alternatively, or additionally, locking members may be provided such asbayonet joints 155 to lock units to the access device 1, once mountedthereto or in combination with mounting thereto.

The apical base plate is preferably made of a rigid, preferablybiocompatible, material. A flexible flange 160 of the access device 1allows for attachment to the cardiac tissue at the outside of the heart10. The flange 160 is for instance made of a biocompatible fabricmaterial, like a woven or nonwoven material. A suitable biocompatiblematerial is for instance Dacron or PTFE. The flange unit 160 isattachable to an outside of the cardiac tissue by suitable attachmentelements. The attachment elements are preferably sutures, hooks, clips,staples, and/or screws, etc. The flange includes for example eyelets forreceiving sutures for stitching attachment of the access device 1 to theheart. Stitches 165 are schematically illustrated in FIG. 11C. Theaccess device 1 is thus reliable attached to the heart while bleedingfrom the heart chamber between heart tissue and the tubular through port120, outside the tube, is prevented by the sealed flange. Bleedingthrough the tubular through port 120 is prevented initially by the tube410 while suturing or by the hemostatic valve, when the transapicalaccess system is retracted from the hemostatic valve.

Alternatively, or in addition to using the tool 4 for creating atransapical hole, the hole may be prepared in a conventional surgicalprocedure using a scalpel. However, this will cause more bleeding thanusing the tool 4.

The tubular through port 120 is protruding from the apical base plate100 and plugged into the transapical hole created in a suitable manner.Preferably the tube of the tubular through port 120 has an outerdiameter slightly larger than the transapical hole, for improved sealingwhen in place.

The flange 160 is for instance attached to the apical base plate 100.The base plate may be made of two plates between which the flange can beclamped upon mounting of the plates together (see also FIG. 11B), suchas indicated by the screws in the base plate 100 in the illustratingFigures.

An example of an apical base plate is illustrated in FIGS. 28A, 28B, 28, C, 28D, 28E, and 28F. FIGS. 28A and 28B illustrate the apical baseplate. FIG. 28C illustrates a top view of an apical base plate. FIG. 28Dillustrated a close-up view of an apical base plate. FIG. 28Eillustrates a cross section of an apical base plate. FIG. 28Fillustrates an apical base plate having two holders connected thereto.

In the example, the apical base plate comprises suture holes 170 tofacilitate attachment therebetween. The flange 160 may be attached tothe apical base plate by sutures.

The access device may thus in use be attached to cardiac tissue whilesealing the interior from the exterior of the heart. The flange 160 maybe sewn to the cardiac tissue, e.g. in a parachute procedure, i.e. thesutures are first fixed to the tissue, e.g. by means of a template 190at the desire apex location. Then the access device's flange is threadedto the sutures and pushed along the sutures to the cardiac tissue. Theaccess device is then advanced over the tube 410 which occupies the holeon the heart wall until the plate and the flange has contact with theheart surface, and the distal opening of the tube of the tubular throughport 120 is inside the heart chamber. The hemostatic valve 2 isconnected to the apical base plate 100 during its attachment to theheart. Finally, the sutures are knotted, and the flange 160 is thustightened to the tissue, such that blood inside the heart does not leakpast the access device 1, bleeding through the access device 1 isprohibited by the hemostatic valve. Alternatively, or in addition, tosutures and/or to the parachute procedure described, tissue glue,staples, hooks, clips, or other fixation means may be provided forsealingly affixing the flange 160 to cardiac tissue. The port 120 is theonly fluid communication when access device 1 is correctly attached tothe apex.

The access device 1 may then be left permanently in place, avoiding theneed to close the transapical hole after a surgical procedure. Theaccess device allows for advantageous access to the heart chamber asdescribed herein.

The template 190 shown in FIG. 2 has an exterior perimeter correspondingto the perimeter of the flange unit 160. In this manner, a suitablecardiac surface at the apex can be determined by applying the template190 to the apex region. The template 190 has markings, e.g. in the formof cut-outs 191, corresponding to elements of the access device 1, e.g.a hole corresponding to the tubular through ports outer diameter. Suchcut-outs or similar markings provide that the access device will beoriented correctly at the apex when attached thereto, e-g- by suturesstitched to the cardiac tissue and affixed to the access device 1, e.g.at flange 160. The template 190 preferably includes holes 192 for suturestitching for reliably attaching the access device 1 to the apex at thesuitable surface for creating the transapical passage through thecardiac tissue.

Alternatively, or in addition to a template 190, the correct positionfor implanting the access device 1 may be found manually by tactilesensing of a surgeon and/or imaging, e.g. ultrasonic, based guidance.

The access device 1 has a first configuration wherein a removablehemostatic valve unit 2 is attached to the base plate. The firstconfiguration is illustrated for instance in FIGS. 5A, 5 b and 5C andFIG. 6 . The port 120 is thus open for fluid communication, controllableby the valve 2 when attached thereto. The valve 2 is (re-)attachable ormountable to the base plate 100 by suitable attachment means. Forinstance, the mounting can be done by threaded attachment (rotation ofthe devices relative each other), screws, bayonet locks, or similar. Thevalve 2 is re-attachable removable from the base plate, e.g. at an endof a procedure done through the valve and access device 1, or when theaccess device 1 has transited to a second configuration where the valveis not needed as for instance sealing is provided by other units such asa sealing unit 3. The removable hemostatic valve 2 has a valve throughport with proximal and distal openings providing a communication channelwith controllable orifice size, e.g. for delivery of various sizedmedical device, to and from the interior of the heart (chamber).

The access device has a second configuration wherein a sealing unit 3with a feed-through port 320 is attached to the base plate 100. Thesecond configuration is illustrated for instance in FIGS. 10A and 10Band FIGS. 11A, 11B and 11C. In this configuration, the port 120 isclosed for fluid communication by means of the sealing unit. Afeed-through port 320, e.g. for medical devices is however provided inthis second configuration of the access device 1. The through port haspreferably a sealing 326 to prevent blood from leaking out of the heart.A sealing surface at the tubular through port's inner portion, like atthe proximal end illustrated e.g. in FIGS. 1A and 1B, may providesealing against a sealing member 325, such as at the outside of thesealing unit, e.g. at its proximal end. This prevents blood leakagethrough the through port when the sealing unit 3 is inserted and affixedto the access device 1.

The second configuration of the access device 1 is provided as analternative or in addition to the first configuration thereof. Thesecond configuration of the access device 1 may be provided in additionto the first configuration during a transition from the firstconfiguration to the second configuration only, e.g. when the sealingunit 3 is delivered to the apical base plate 100 through the hemostaticvalve unit attached to the apical base plate 100. This has the advantageof avoiding blood leakage when changing configuration of the accessdevice 1. A transition from the first to the second configuration isillustrated for instance in FIGS. 8A and 8B. A co-existent first andsecond configuration is illustrated for instance in FIGS. 9A and 9B.

As can be seen in FIGS. 8A and 8B and 9A and 9B, the sealing unit 3 ofthe access system is in examples configured to be delivered through thehemostatic valve unit 2 for a transition from the first configuration tothe second configuration. In the second configuration, the separation isprovided between the wet zone and the dry zone.

The hemostatic valve unit 2 may include one or more units to control theopening cross-section or aperture of a port 210 of the valve. These oneor more units to control the aperture may, like housing 200, besplittable for instance for peel-on and/or peel-off of the units asdescribed herein. Splittable is preferably provided by a construction ofat least two parts joined together to form one unit. For instance,mechanical, or magnetic, preferably releasable joints may be providedfor the joints. In particular, as illustrated in the Figures, thehousing parts are preferably splittable in an axial/longitudinaldirection of the valve unit 2. In this manner, the housing parts arepreferably removable radially outwards, herein called “peel-off”operation. Other unit(s) may then be providing sealing of the wet dryzone of the apical base plate, such as the bellows described herein.Re-assembly may be made in a reverse radially inward assembly of suchhousing parts of a valve unit 2, herein also called “peel-on” operation.

Such unit may move or size suitably for such control. Examples of unitsinclude inflatable balloons, leaflets (moveable or fixed), and/or flaps(moveable or fixed). The aperture may be controlled by units similar tocamera lens aperture diaphragms or iris like units. The units mayalternatively or additionally include directional flow control elements,such as valves. The controlled directional flow may be uni-directional,i.e. in one direction only, or bi-directional, i.e. in two directions(forward, backward flow).

FIGS. 3A and 3B illustrate a hemostatic valve unit 2 while FIGS. 4A and4B illustrate example of two different inflatable balloon configurationsof hemostatic valve units 2. The removable hemostatic valve isconnectable to the through port 120, i.e. a fluid communication channelis provided through the hemostatic valve to the through channel 120. Thehemostatic valve 2 may for instance include one or more sealing elements(not shown) suitably arranged against the access device 1. For instance,such sealing elements may be provided as pressing against the apicalbase plate proximal side and/or a proximal end portion of the tubularthrough port 120.

The hemostatic valve unit 2 includes a housing 200 with approximal endand a distal end. The housing 200 may be splittable for instance forpeel-on and/or peel-off of the hemostatic valve unit 2 as describedherein. The distal end is affixable to the access device 1. The endsinclude an opening for access to a through channel of the valve 2. Thethough channel includes an inflatable balloon, via an inflation port210. The inflation pressure provides a more or less restricted passagethrough the through channel of valve 2, i.e. the orifice of the valvethrough port 225 is variable by the inflation pressure (as illustratedby the double headed arrow in FIG. 4A). Devices inserted through thethrough channel may have varying diameter or cross-sectional shape,wherein the balloon pressure is adapted to this cross section to providea reliable sealing. In this manner, the through channel of valve 2accommodates a large range of devices diameters and cross-sectionalshapes. As shown in FIG. 4B, the balloon 220 may have multiple lobes tofurther improve the adaptability to and range of different diameters orcross-sectional shapes of devices accommodatable for passage through thethrough channel of the valve 2 while safely providing reliable sealingand leakage protection of blood from the interior of the heart to theoutside of the heart.

The hemostatic valve unit 2 is illustrated removably affixed to anaccess device 1 for instance in FIGS. 5, 6, 8, and 9 . A sealing surface230 is provided for fluid tight sealing against a sealing surface 130 ofaccess device 1, such as at the apical base plate 100. The sealing mayinclude a sealing member, such as an O-ring for improved sealing.

The hemostatic valve can for instance be reliably removably affixed toan access device's 1 via a bayonet joint 155 including bayonet pins 255.

As shown in FIGS. 25A, 25B, 25C, 25D, and 25E, the housing 200 of valve2 is in examples splittable, with 202, 204 splittable housing parts ofthe valve 2 as mentioned above. In this manner, the valve 2 can bedisassembled from parts that are positioned in its through port 225.Blood leakage may effectively be prevented by other parts, e.g. as shownin FIG. 24A. An access device 1 with affixed sealing unit 3 providesbleeding prevention as described above. With a medical device having alarger proximal diameter than the through port 225, the valve 2 cannotbe withdrawn proximally for removal from the aggregate. There can bemechanical obstacles preventing that the valve 2 is retracted. Forinstance, a drive unit 6 may be affixed proximally to the aggregate ofaccess device 1 and sealing unit 3 as shown in FIG. 24A. The splittablevalve 2 may then advantageously removed from the aggregate upon assemblyof the other parts by deflating the balloon 220 and splitting the valve2. The valve 2 is arranged to be peeled off. The split parts of valve 2can then be removed from the patient as valve 2 is no longer needed.Alternatively, or in addition, the splittable valve 2 may be opened onlywhile parts still are connected to each other. For instance, twoadjoining parts of a splittable valve with several parts may beseparated from each other for opening the splittable valve 2, whilestill having part being adjoined, e.g. by a hinge, splint, string, orsimilar joint (like an open ring). Alternatively, or in addition, thevalve 2 can be subsequently re-assembled and for instance re-attached toan apical base plate as desired (e.g. peel-on), either during the sameprocedure or at a later time after adequate sterilization.

Examples for peel-on and peel-off of a hemostatic valve 2 may be appliedin reverse for each of these operations, respectively.

A valve 2 may later be re-attached, for instance to a configuration asshown in FIG. 24A if sealing is desired again, e.g. for repair orreplacement of components of the aggregate or other parts of the system.The access device 1 thus provides for a re-access to the inside of theheart 15 at a later point in time.

The access device 1 may comprise a drive unit 6 of a cardiac assistdevice connected to the base plate in the second configuration. A rod610 (FIG. 11A and FIG. 23 ) may transfer a movement generated by thedrive unit into the heart chamber for cardiac assist. The distal end ofthe rod 610 may be connected to an anchor at a heart valve region, likeanchor unit 650 in the example of an annuloplasty implant.

An anchor unit in the form of an annuloplasty implant is described inunpublished PCT application of the same applicant with PCT applicationnumber PCT/EP2019/068597 filed 10 Jul. 2019, which is incorporatedherein by reference in its entirety for all purposes, but in particularthe description of the chain annuloplasty ring and delivery system shownin FIGS. 24 to 42 and the corresponding description.

Coupling of the rod may be made magnetically, e.g. with a sealing unit 3shown in FIGS. 24A, 24B and 24C. A magnetic coupling 340 at the distalend of the sealing unit may provide advantageous coupling with a firmlink at the coupling point that allows for rotational movement andadaptation of the movement. A hollow in the magnetic coupling may beprovided as a hollow funnel for receiving a spherical ball coupling toallow for this movement and geometrical adaptation during assembly andoperation of the assist unit. Such a magnetic clutch coupling provides anumber of advantages, for instance an overload protection. The magneticconnection can be configured such that it uncouples at pre-definedthreshold forces to avoid tissue damage. The uncoupling possibility ofthe magnetic clutch coupling also allows for easy repair of componentsof an assist system, e.g. for repair, replacement or removal thereof.

Coupling means are described in unpublished PCT application of the sameapplicant with PCT application number PCT/EP2019/068595 filed 10 Jul.2019, which is incorporated herein by reference in its entirety for allpurposes, but in particular the description of the coupling unit 200 andextension units 400, including magnetic and linked joint couplings asfor instance shown in FIGS. 5 and 6 thereof as well as the correspondingdescription.

In FIGS. 7, 8, 9, 10, 11, 22, 23 and 24 examples of sealing unit 3 areillustrated in various configurations.

The sealing unit includes in examples a membrane or bellow 310 and afeed through port 320. The feed through port may be completely sealedwith no through going opening, such as for magnetic couplings.Alternatively, or in addition, a feed through port may have a distalopening for feeding through an element like a rod 610. The distalopening is then provided with a sealing member 326, such as an O-ring,for sealing the feed through port and providing the separation of thewet zone and the dry zone while allowing for a movement transferredbetween the zones. The sealing unit thus allows for instance reciprocalmovement, e.g. in a cardiac assist/driving unit arrangement for safereciprocal movement over millions of repeated cycles without leakage.

The membrane or bellows is preferably in examples made of an elasticand/or flexible material, such as silicone or the like. Bellows may bemade of metal material like biocompatible metal materials such asTitanium or Nitinol. The bellows is movable in a longitudinal direction,e.g. for reciprocal cyclic movements. It is also moveable radiallyallowing for free motion or rotation as described herein. In examples,the bellows is rotating simultaneously as the bellows moves in operationin a longitudinal direction. In this way, there will be a rotation of abellows upon forward and backward reciprocal movement, causing thebellows to have a type of threaded motion or corkscrew like motion. Thiscombined motion is for instance providable by such elastic and/orflexible material of the bellows. A bellows which allows for rotationmay have beneficial features since it would mimic the natural musclecontraction causing a helix heart movement. Such advantage features maye.g. be lower friction of the bellows. Other advantage features may e.g.be less stress and tension on the bellows causing a longer lifetime ofthe bellows.

In case the through channel is desired to be closed, this may be done bymeans of a plug (not shown) insertable into the through port 120.

FIGS. 3, 4, 5, 6, 8, 9, 19, 20, 21, 24 and 25 illustrate example of ahemostatic valve unit 2 in various configurations.

A hemostatic valve unit 2 has a housing 200 with a distal end and aproximal end. It is removably connectable at the distal end thereof toan apical base plate 100 of an access device 1 for a heart 10. The valveunit 2 includes a pneumatic valve in a through channel 225 of the valveunit 2 between the distal end and the proximal end thereof.

The pneumatic valve is for instance a balloon valve or a tube coil forcontrolling an inner passage in a through channel of the valve. Aballoon valve has generally a larger range than a tube coil, which inturn can be provided with reduced height of the valve. A balloon valveis schematically shown in FIG. 4 , while the valve shown in FIG. 25 mayhave a tube coil, for controlling the passage in the through channel.

The housing 200 has a proximal end with an opening to the through port225 of the valve unit 2, such as for receiving a medical device to bepassed through the inner passage of the valve unit 2.

The hemostatic valve unit 2 can in examples include a pneumaticreservoir unit (not shown) for maintaining a substantially constantpressure on the pneumatic valve.

In some examples the housing 200 is splittable. It has for instancemultiple splittable housing parts 202, 204. As shown in FIG. 25 . Thisallows for the herein described advantageous peel off when the valve issplit.

The valve unit 2 may be re-usable.

In FIG. 4A a single lobe “donut” balloon is illustrated.

In FIG. 4B a balloon with multiple lobes 222 is illustrated.

An inflation port 210 is connectable to a pressure regulation source forcontrolling the pressure in the balloon. Various pressures provide forvarious expansions of the balloon, and also for varied pressure ondevices introduced into the through port 225 and in apposition to theballoon's exterior wall. Sealing is thus secured over a wide range ofcross sections of devices to be entered through the port 225. Forinstance, a small needle or comparatively large tube can be enteredthrough the valve without bleeding.

In FIG. 5 , the valve 2 is illustrated attached to an access device 1.This assembly is illustrated in FIG. 6 being attached to the heart 10creating a transapical access to a heart chamber.

In FIGS. 19A and B, the hemostatic valve 2 is illustrated attached tothe applicator tool 4 over the tube 410, and in FIGS. 20A and B attachedto a delivery system 7 for delivering medical devices into the heart, asillustrated in FIG. 21 . A delivery tube 70 of the delivery system isconfigured to be inserted into the heart chamber 20. The delivery tube70 is in the example shown inserted through the access device 1 withattached valve 2 (see FIG. 6 ). The distal end of the delivery tube 70is in the example advanced through the left ventricular chamber towardsthe left atrial chamber. A pusher 74 may be used to advance medicaldevices or other medical system assembly components through the deliverytube 70 to the inner of the heart. The delivery system may include afunnel shaped inserter unit 72 for facilitating insertion of suchdevices and components into the proximal end of the delivery tube 70.For instance, an anchor unit 650 may be delivered through the deliverytube 70 to the cardiac valve area as illustrated in FIGS. 21 (at distalend of delivery tube 70) and in FIG. 23 (delivered and attached to valvearea and also a rod 610). The anchor unit is for instance theannuloplasty chain implant mentioned above and described in PCTapplication number PCT/EP2019/068597, and in particular the chainannuloplasty ring and its delivery system shown in FIGS. 24 to 42 andthe corresponding description therein. A chain annuloplasty ring may beaffixed to a cardiac annulus, like the mitral valve annulus asillustrated, by means of multiple anchor screws (not shown). Thesescrews may be rotated into the annulus tissue by suitably attachedscrewdrivers (not shown) having proximal ends accessible for rotationpassed through a lock of the inserter unit 72.

Once, the anchor unit 650 is installed, a driving rod 610 can beattached to the anchor unit 650 via the access device 1. The rod 610 mayfor instance be pre-installed through a sealing units' 3 feed-throughport 320 and installed together into the access device 1 through ahemostatic valve 2 as described herein. The rod 610 may also beinstalled first and then the sealing unit 3 is then installed with itsbellows over the rod 610 through the valve 2. The valve 2 can then beremoved while drive unit 6 becomes connected to the driving rod 610 andaccess device 1, leaving a wet dry zone separation implanted in thepatient with the cardiac assist system installed.

In FIGS. 12-19 examples of applicator tools 4 for advantageouslycreating a transapical passage on a beating heart are illustrated, forinstance with a tube 410 that has a sharpened edge at a distal endthereof.

The applicator tool includes in examples a harpoon 450 insertablethrough a tube of the applicator tool. The harpoon 450 includes a rodmember 470 that is housed inside a hollow penetration needle 460 thathas a distal tip for penetrating cardiac tissue at an apex of a heart.The rod 470 member is preferably a solid rod with an expandableretention member 473 at the distal end 472 of the rod. The rod 470 isarranged longitudinally movable in the penetration needle. Thepenetration needle is inserted into the tube 410 and arrangedlongitudinally movable in the tube 410. The rod is preferably keptlongitudinally stationary with the penetration needle 460 when it islongitudinally moved. The tube 410 has preferably a sharpened edge at adistal end for cutting the cardiac tissue at the apex.

In a first step, tube 410 is brought with its distal end into appositionat the desired location of the apex. The penetration needle 460 may bepushed at that location, such as determined with template 190, out ofthe tube 410 through the cardiac tissue to the chamber. The needle has asmall enough diameter that substantially no bleeding occurs across thecardiac tissue at the puncture site. The harpoon 450 is stored in thepenetration needle with expandable flanges in a collapsed configurationwithin the needle lumen and proximal to the sharp tip thereof, see FIG.13A

The distal end of the tube 410 may be brought into apposition at thedesired apex region and then the penetration needle may be pushedthrough the apex. For instance, the penetration needle may be releasablyactivated by a trigger 465. The trigger releases the needle and it ispushed forward by a spring 466 released by the trigger 465. The needleis “shot” through the cardiac tissue in a quick and reliable manner.

FIGS. 15 and 16 illustrate a detail of the applicator tool 4. Moreprecisely, the proximal end portion of the penetration needle 460housing the proximal portion of the rod 470 are shown. The rod 470 has ashoulder 471 such that the rod can be longitudinally moved relative thepenetration needle 460. The shoulder provides a stop in the proximaldirection, such that the relative position of the rod 470 to thepenetration needle 460 in its retracted position is provided, see e.g.FIG. 13A for the distal end of the rod 470 retracted into the distal tipof the penetration needle 460. The seat 461 of the needle provides thatupon triggering a forward push of the needle 460 and rod 470 aggregatecan be shot together forward, e.g. by releasing the needle spring 466 intension by activating the needle trigger 465, see e.g. FIG. 15, 17 or19A and 19B. A safety pin 467 may be provided preventing unintendedactivation of the trigger 465. The rod 470 can then be moved in thedistal direction with its distal end out of the penetration needle's 460distal end for expanding the one or more retaining units 473.

Thus, once the penetration needle is positioned through the cardiactissue, the harpoon 450 may be pushed forward out of the penetrationneedle distal end. This may be done by pushing the proximal end 455 ofthe harpoon 450 in the distal direction while the penetration needle 460is kept in position, for instance as described in the previousparagraph. The expandable flange is then expanded, e.g. by an elasticforce thereof. The flange provides thus a retainer element forpreventing withdrawal of the harpoon through the cardiac tissue, asillustrated in FIGS. 13B,C and 14B. A moveable and lockable stop element474 may be provided for keeping the rod locked in position relative thegrip 400 and/or tube 410, as illustrated in FIGS. 18 and 19A.

The harpoon with expanded retainer unit is then withdrawn towards thecardiac tissue, i.e. at the inner wall of the heart chamber. Theshoulder 471 at the proximal end portion of rod 470 and expandedretaining unit 473 are abutting against the penetration needle. In thismanner, the aggregate rod 470 and penetration needle 460 can bewithdrawn proximally as a unit, e.g. by manually drawing the proximalend 455 in the proximal direction.

The tube 410 is then pushed forward towards the retainer unit throughthe cardiac tissue, wherein the flange is configured to keep the cutcardiac tissue within the tube 410, as illustrated in FIGS. 13D and 14C.Tube 410 is arranged longitudinally moveable and is for instance pushedforward by using the trigger 415 in a safe and reproducible manner. Thetrigger 415 may be arranged to articulate a claw 417 that pushes thetube 410 when the trigger is activated accordingly. When pushing thetrigger, the claw tilt slightly against the outside of the tube 410 andlocks in place for the pushing action. Releasing the trigger 415 removesthe tilting of the claw 417 which then can slide back over the tube 410for the next forward trigger movement. This provides for preciseactivation of the movement with a compact mechanism. The cut cardiactissue from the transapical hole thus created is safely kept inside thetube 410, as schematically illustrated in FIG. 14C as a tissue plug 475.

The tube 410 may be pushed forward, e.g. by operation of a trigger 415of the grip 400. The tube may be suspended freely rotatable around itscentral axis. Cutting may be facilitated by rotation of the tube whenmoving through the cardiac tissue. Rotation of the tube may be providedby a control dial 420. In this manner, a quick, precise and efficienttransapical hole is made. This is done with improved patient safety asembolization of cut cardiac tissue is prevented. The tissue that is cutis safely kept in the tube 410 with the harpoon flanges holding back thetissue in the tube, as illustrated in FIG. 13D. Complications likestroke are minimized or avoided by such examples of applicator tools forcreating a transapical passage on a beating heart, which is a particularchallenge because of the heart movements and related difficulties tocontain cut tissue and prevent it from being entrained with the bloodflow of the beating heart for instance.

The tube 410 has an outer diameter thus substantially corresponding tothe diameter of the punched transapical hole in the cardiac tissue. Incase a tubular through port 120 is installed in the transapical hole viasaid tube 410, the through port 120 outer diameter is slightly largerthan the diameter of the transapical hole. Tissue around the transapicalhole may thus elastically flex towards the outside of the through port's120 tube and thus improve both ingrowth and sealing of the access device1.

The distal end of the tube 410 is in examples in fluid communicationwith a proximal seal including a blood indicator 490. Blood entering theblood indicator via the tube 410 indicates penetration of the cardiactissue into an interior/chamber 20 of the heart 10. As illustrated inFIGS. 19A and 19B, the applicator tool 4 can in examples also deliver amedical device. For instance, the device is arranged over the tube's 410outside and can slide over the tube 410.

The medical device is arranged to be matingly received with an innerchannel of the device slidable over the tube's 410 outside. It can forinstance be slid onto the tube from the distal end thereof for assemblyas shown in FIG. 19A. A conical protection unit may temporarily be puton the distal end orifice of the tube 410 for sliding the medical deviceonto the tube, for instance to cover a sharp edge 412 of the distal endof the tube 410.

In FIG. 19B the device is illustrated being slid forward.

In an example, the device incudes an apical access device 1. The devicemay include a hemostatic valve unit 2 removably pre-attached thereto.

The apical base plate can be slid forward over tube 410 and with itstubular through port 120 into the through hole, still with the distalend of tube inserted through the cardiac tissue. When the flange unit160 is sealingly attached to the apex, the applicator tool can bewithdrawn out of the port 120 and the valve unit 2. This leaves theaggregate of an access device with attached valve unit 2 in position asshown in FIG. 6 .

The transapical port is then usable, e.g. for delivery of devices to theheart chamber or performing procedures as desired. Eventually thesealing unit 3 may then be installed for providing the wet/dry zoneseparation. A medical device like a driving unit of a cardiac assistdevice can be installed at the dry zone of the access device 1. Thevalve unit may be removed. The procedure can then be concluded, leavinga wet/dry zone separated device implanted in the closed patient body.

FIG. 18 illustrates an example of an applicator tool for creating atransapical passage that includes a penetration needle insertablethrough a co-axial dilator 480 of the tool. The penetration needle 460has a distal tip for penetrating cardiac tissue at an apex of a heart.

This example does not include a harpoon. However, a tool 4 as describedpreviously with a harpoon-based tissue retaining member and cutting tubemay provide for preparation of a hole substantially lesser than atubular through port 120 (not shown in the Figures). The diameter of thehole may then be widened by a dilator 480. The applicator tool 4 mayfurthermore include an access device for a heart that has a tubularthrough port to be arranged across the cardiac tissue when advanced overthe dilator. Also, a removable hemostatic valve unit 2 may be includedin examples of such a tool 4 attachable to the access device 1 andslidable over the dilator 480.

Hence, a transapical access system 5 for creating a transapical passageon a beating heart is provided. The system includes an access device fora heart according to the afore described aspect of the disclosure. Inaddition, the system includes an applicator tool for creating atransapical passage and delivering the access device to an apex of theheart, as described above according to the afore described aspects ofthe disclosure.

The system may include a fixture template 190 for targeted puncture ofthe apex. The fixture may be provided in examples with a patientspecific shape for the apex of a particular patient's heart 10. Thespecific shape may be selected from multiple pre-manufactured fixturesof different shapes. The template 190 may be manufactured with aspecific shape based on imaging data of the apex, for instance CT basedimaging data.

FIG. 23 illustrates an example of a medical system including a cardiacassist unit transapically implanted. A drive unit 6 of the cardiacassist unit is illustrated attached to a sealed apical base plate 1which is implanted and providing a transapical passage with a wet/dryzone separation as described above. Hence, the mechanical and electronicparts in the drive unit are in a dry zone (inside its housing and insidethe sealing unit 3). A driving rod 610 is attached to an anchor unit650. In FIG. 22A, B and FIG. 23 the electronic parts in the drive unitmay have a cable through-port for electrical connection 630 of a cableto e.g. an external cell, battery or other power supply. An illustrationof such an electrical connection 630 is seen in FIGS. 22A, B and FIG. 23. Note that the tread shown at electrical connection 630 is optional oralternative for securely connecting a cable. The cable through-porttypically ends up in an electrical connection for instance in the formof e.g. a Bal Seal connector like a “Bal Conn® Electrical Contact” or a“SYGNUS® implantable contact system” or similar connection systems, suchas on top of the housing

The access device 1 is in examples a cardiac anchor unit as part of animplantable medical device system. A cardiac anchor unit and cardiacassist principles are for instance disclosed in WO 2011/119101A1 of thesame applicant that the present application, in particular in FIG. 11 cthereof and related description regarding a left ventricle arrangementfor assisting the mitral valve piston like movement. This document isincorporated herein by reference in its entirety, and in particularregarding FIG. 11 c . The access device 1 provides a particularadvantageous implementation of such a cardiac assist system. Accessdevice 1 may also be used in cardiac assist systems involving otherconfigurations than disclosed in WO 2011/119101A1.

If further anchor units are present at the heart, like shown in FIG. 23, a relative movement is providable by the driving unit, e.g. via therod 610. The access device 1 when implanted at the apex may be regardedhaving a static position, and a second anchor, like the chainannuloplasty anchor mentioned above, may be moved in a push/pullmovement, e.g. synchronized with the heart's ECG, intracardiac pressure,cardiac output flow, or the like, for assisting the heart's pump actionand thus treatment of a patient.

FIGS. 11A, 11B and 11C illustrate an example of a sealed apical baseplate 1, which includes a connection interface 110 for matinglyengagement of multiple medical devices. An example is the hemostaticvalve 2 and the drive unit 6 that may be attached alternatively to thesame connection interface. The multiple medical devices have in turn amating connection interface designs for connection to the apical baseplate, respectively.

In some examples, the connection interface is positioned on a proximalside of the apical base plate 1, and the apical base plate 1 is sealedon a distal side, opposite its proximal side.

The connection interface 110 may include a locking unit 115 in certainembodiments. The locking unit provides for secure mating engagement ofthe apical base plate 1 with such multiple medical devices when attachedto each other. An example of a locking unit 115 is shown in FIG. 3A.

As is shown in the example of the apical base plate in FIGS. 28A, 28B,28C, 28D and 28E, the apical base plate may comprise various connectioninterfaces 110 for mating with a medical device. In one example, aconnection interface 110 may be an edge for e.g. matingly engagementwith e.g. a locking clip. In another example the connection interface110 may be a screwing hole e.g. for screwing in a screw, for example ofM2 size, any suitable size may be used. In yet another example, theconnection interface 110 may be a connection hole or a connection loope.g. for matingly engagement with e.g. a suture, a wire, a thread, afiber or similar. By way of example, FIG. 28F illustrates the apicalbase plate having two holders connected to one of the illustratedconnection interfaces 110. It is to be noted that the apical base platemay comprise one or more connection interfaces 110. In some examples,more than one different connection interfaces 110 may be applied.

FIG. 26 illustrates steps of an example of a method 700 of creating atransapical passage on a beating heart.

The method or medical procedure includes determining a position 710 onan apex region for creating a transapical passage. This may for instancebe done using an imaging modality providing suitable image data forprocessing and analysis, e.g. CT based, MR based, Ultrasonic based.Alternatively, or in addition, the position may be determined by tactilesensing and/or visual inspection of the heart, e.g. during surgery.

The method further includes creating a transapical hole 720 at thedetermined apex region through cardiac tissue, such as by punchingand/or cutting through the tissue.

Creating the transapical hole may advantageously be performed using anapplicator tool 4 as described above and illustrated in FIGS. 12 to 19 .Creating the transapical hole may include penetrating cardiac tissue atthe apex with a penetration needle 460 housing a distal tip of a harpoon450 and through a tube 410. The forward penetration movement of theharpoon member and penetration needle 460 may be released by a trigger465 so that these are “shot” forward as a unit in a one-shot movement,here through the apex wall. The one-shot movement is quick and reliablefor making the initial puncture of the cardiac tissue.

When the harpoon is brought through the cardiac tissue, a rod member maybe further advanced out of the penetration needle and one or moreretention members may be expanded radially outwards from the rod's 470distal end 472. The retention member is then withdrawn for appositionagainst the inner cardiac wall of the heart chamber at the puncture madeby the puncture needle 460 (which is also suitably withdrawn into thepuncture).

The sharpened edge 412 of the tube 410 is then pushed through thecardiac tissue towards the retention member. Pushing of the tuberelative the rod member distal end 472 may be done by operating thetrigger 415 of the pistol grip 400 in a safe and repeatedly standardizedmanner. In addition, a control dial 420 may be used by an operator forrotating the tube when cutting for improved cutting.

The expanded diameter of the retention member is preferably slightlysmaller than the inner diameter of the tube 410 lumen so that the tissueplug can be completely withdrawn into the tube's 410 inner lumen, asillustrated in FIG. 13D. The retention member may also have a largerdiameter. It may be brought into apposition with the sharp edge 412 ofthe tube 410. Thus, both retaining the tissue plug in the tube andcovering the sharp edge, preventing potential unintended cutting by theedge 412 and increasing safety of the procedure both for patients andoperators. In any case, embolization of the cut tissue plug from theapex is securely prevented.

The penetration of the cardiac tissue into the heart chamber an interiorof the heart may be indicated to the operator with a blood indicator ofthe applicator tool 4. For instance, the blood indicator 490 may beprovided at distal end of a tube of an applicator tool being in fluidcommunication with a proximal seal. The seal may include a transparentportion blood passing from the chamber into the distal end and the lumenof tube 410 passes through the tube 410 to its proximal end andindicates penetration of the cardiac tissue into an interior of theheart. The seal provides also for feed through of the penetration needleand rod member therein without leakage.

A dilator 480 may be used for widening the tissue hole created by thepenetration needle 460 and/or the tube 410

The method further includes delivering 730 an access device, such as anapical base plate, which has a tubular through port to the transapicalhole. Delivery may be made by sliding the access device distally overthe outside of tube 410 and/or a dilator 480.

The method further includes attaching a flange unit of the access deviceto an outside of the heart. The flange unit may be attached around thetransapical hole by a suture technique called “parachute technique”. Forthe parachute procedure, both ends of a single suture 165 are suturedthrough the cardiac tissue around the hole at a suitable distance to thehole. This may be done using a suitable template for a number of suturesaround the hole. For instance, 8 to 10 sutures around the periphery ofthe flange 160 may be sufficient for providing reliable seat of theaccess device in a sealed manner, i.e. without bleeding from the heartchamber when the channel in tube 120 is suitably closed by e.g. ahemostatic valve, sealing unit or a plug. The channel in tube 120provides a transapical working channel to and from a heart chamber on abeating heart.

Bleeding is prevented by keeping the tube 410 in the hole. The two endsof each same suture are then passed through the flange unit, which isheld away from the heart surface on the outside of the tube 410 of tool4. The suturing pattern is repeated using additional sutures, resultingin several suture “pairs” spaced around the hole and tube 410. Theaccess device 1 is then lowered or parachuted down against the outerheart wall and advanced until the plate 100 and the flange 160 are incontact with the heart surface and the opening of the tube 120 of theaccess device 1 is inside the heart chamber. After all the suture pairsare secured, e.g. by suitable knots, the result is a blood tight flangewith a tubular port 120 in the transapical hole.

The method may further include removably connecting a hemostatic valveunit 2 to the access device 1. The hemostatic valve unit 2 may bepre-mounted on the tube 410 and positioned at the access device 1 bysliding along the tube 410. Alternatively, the hemostatic valve unit 2may be pre-mounted and releasably attached on the access device 1 andpositioned in the transapical passage by sliding along the tube towardsthe apical puncture hole as described above.

The tube 410 of the applicator tool may then be retracted. It iswithdrawn out of the access device and valve that remain in place at theheart, as shown in FIG. 6 .

A medical procedure and/or delivery of medical devices may be performedthrough the port of the valve 2 and the port 120. The method may includefor example transapically passing a driving rod 610 of a cardiac assistsystem into the heart through the hemostatic valve 2 and access device1.

Delivering medical devices to the heart chamber may include deploying anannuloplasty chain ring at a cardiac valve annulus. A delivery catheterof a delivery system may be introduced for this purpose through theaccess device 1 with affixed valve 2. The delivery catheter may then beremoved out of the patient. Blood leakage from the heart is continuedprevented by the hemostatic valve unit 2.

A sealing device may be slid over the driving rod 610 through the valve2 and affixed at the access device 1 providing a sealed access device 1with a wet/dry zone separation. The proximal end of the driving rod 610may then be connected to a drive unit 6 while attaching the drive unit 6to the access device 1.

The sealing device 3 may be introduced through the hemostatic valve unit2 to the access device 1 sealing the transapical passage, e.g. asdescribed above for creating the wet/dry zone separation. An elementlike a rod may pass across the through port of the sealing element 3.Alternatively, the distal end port of sealing unit 3 may be provided asa closed element like a membrane or hub. A magnetic coupling 340 to anelement in the heart chamber may be established with units shown inFIGS. 24A, 24B and 24C.

The valve 2 may then be removed as well as a medical device affixed tothe access device prior to concluding the procedure. The method 700 mayinclude removing the hemostatic valve unit from the apical base plate bydisconnecting the hemostatic valve unit from the apical base plate andwithdrawing the hemostatic valve unit out of the patient, or splittingor partitioning the hemostatic valve unit.

In addition, examples of the disclosure may include one or more sensors.For instance, the access device 1, the hemostatic valve 2, the sealingunit 3, the drive unit for cardiac assist 6, the transapical accesssystem 5, or other medical devices (not shown) attachable to the accessdevice 1 may include such sensor(s) thus implantable into a patient'sbody.

Sensors often need to be part of a wet zone and a dry zone, sincemeasurement is often performed in blood (wet zone) and sensors ofteninclude electrical parts that need to be separated from blood in a dryzone. Thus, it is important to have a feed-through port 320 in order tofacilitate this sensor wet and dry zone separation.

Hence, some examples of the disclosure include in addition one ormultiple optional sensors 620.

Such sensor may go through the feed-through port 320 of the bellows 310,instead of the driving rod 610 as previously described. In anotheralternative/example, there may be more than one (multiple) feed-throughports 320 so that multiple sensors and/or the driving rod 610 could gothrough different feed-through ports 320 at the same time. Thefeed-through port 320 does not need to be part of the bellows 310, asprevious described, but may be a separate part/unit of the sealing unit3 instead. An example of a multiple feed-through, or multi-lumen, ports320 is for instance including a preferably separate channel for asensor, such as a pressure sensor, (not shown in the Figures).

In one example, the sensor 620 may include one or more pressure sensorse.g. connectable to a port distally ending in the chamber of the heart.This will provide intracardiac pressure of e.g. the left and/or rightventricle of the heart. The pressure data not only provides importantclinical data but may also be used in control algorithms of an implantedmedical device. Other relevant clinical parameters, e.g. the heart rateof the patient and/or various heart arrhythmias, may also be extractedfrom the pressure data.

In one example, the sensor 620 may include additionally, oralternatively, one or more ECG electrodes e.g. connectable to a portdistally ending in the heart. This will provide intracardiac electricalactivity of the heart. The ECG data not only provides important clinicaldata but may also be used in control algorithms of an implanted medicaldevice. Other relevant clinical parameters, e.g. the heart rate of thepatient and/or various heart arrhythmias, may also be extracted from theECG data.

In one example, the sensor 620 may include additionally, oralternatively, one or more optical and/or electrical sensors used forobtaining blood flow and/or blood volume measurements in the heart. Suchsensors may e.g. be placed in an optical port and/or window (not shown)facing towards the wet zone of the heart. This may e.g. providemeasurement data for intracardiac blood volume of the left ventricle ofthe heart. The blood flow/volume data not only provides importantclinical data but may also be used in control algorithms of an implantedmedical device. Other relevant clinical parameters, e.g. the heart rateof the patient and/or stroke volume and/or cardiac output and/or SpO2,may also be extracted from the blood flow/volume data.

In one example, the sensor 620 may include in addition, oralternatively, one or more movement sensors e.g. connectable to a portdistally ending in the heart and/or connected to the driving rod 610.This will provide measurement data for intracardiac movement and/oractivity data of the heart. The movement data may e.g. represent the upand down movement of the mitral valve and/or the atria/ventricle plane.The movement data not only provides important diagnostic clinical databut may also be used in control algorithms of an implanted medicaldevice. Other relevant clinical parameters, e.g. the heart rate of thepatient and/or various heart arrhythmias, may also be extracted from themovement data. Examples of movement sensors include magnetic based, suchas a Hall effect sensor, and/or optical based. Examples of movementsensors may also include one or more accelerometers.

The measurement data obtained from the sensor(s) 620 may for instance beused to control a medical device, e.g. be part of a control algorithmimplemented in the hardware and/or software of the medical device suchas a cardiac assist system. The data from the sensors may for instancealso be used to monitor important physiological properties and/or usethe sensor data to extract and/or calculate critical clinical parametersthat need to be monitored. Besides from monitoring the physiologicalproperties and/or clinical parameters, they may be part of asurveillance system. Obtaining and managing patient data is not onlyimportant for e.g. the safety of the patient and the functionality of amedical device, but also due to regulatory requirements for medicaldevices since it will be mandatory to collect, retain, and analyzepost-market clinical data.

Such measurement data, providable by sensors 620, when implanted withexamples of devices described herein, has hitherto been difficult toprovide.

FIG. 27 illustrates steps of an example of a method 800 of transapicallyimplanting a cardiac assist system. The method 800 or medical procedureincludes attaching 810 a cardiac assist unit 6 to an access device 1including a sealed apical base plate 100. The apical base plate 100 hasa sealed tubular through port arranged across cardiac tissue to a heartchamber. A flange unit is attached to the base plate 100 and to theheart 10. The access device 1 has a sealing unit 3 attached thereto. Themethod may include inserting a delivery tube through a hemostatic valveattached to the access device prior to sealing the access device forproviding a wet/dry zone as described above.

Some additional examples of the disclosure are given below.

Example 31. An applicator tool (4) for creating a transapical passage ona beating heart, said applicator tool (4) including

a harpoon (450) insertable through a tube (410) and having a distal tipconfigured to penetrate cardiac tissue at an apex of said heart; and

said tube (410) having a sharpened edge at a distal end configured tocut said cardiac tissue at said apex to a transapical hole in saidheart, and said harpoon having an expandable flange for preventingwithdrawal of said harpoon through said cardiac tissue, wherein saidflange is configured to keep said cut cardiac tissue within said tube(410).

32. The applicator tool of example 31, wherein said distal end of saidtube is in fluid communication with a proximal seal including a bloodindicator (490).

33. The applicator tool of example 31 or 32, wherein said distal end ofsaid tube (410) is configured for apposition to said cardiac tissue atsaid apex.

34. The applicator tool of any of examples 31 to 33, comprising

an access device (1) for a heart having a tubular through port (120)adapted to be arranged across said cardiac tissue when advanced oversaid tube (410).

35. The applicator tool of example 34, wherein a removable hemostaticvalve unit (2) is attachable to said access device (1) and slidable oversaid tube (410).

36. The applicator tool of any of examples 31 to 35, in combinationcomprising a dilator having a larger diameter than said transapical holein use made in said heart by said tube (410) and said dilator beingconfigured to widen said transapical hole when inserted therein.

Example 37. An applicator tool (4) for creating a transapical passage ona beating heart, said applicator tool (4) including

a penetration needle (460) insertable through a co-axial dilator (480)having a distal tip configured to penetrate cardiac tissue at an apex toprovide an opening, and said dilator (480) to widen said opening of saidcardiac tissue; and

an access device (1) for a heart having a tubular through port (120)adapted to be arranged across said cardiac tissue when advanced oversaid dilator (480), and/or wherein said distal end of said penetrationneedle is in fluid communication with a proximal seal including a bloodindicator.

38. The applicator tool of example 37, wherein a removable hemostaticvalve unit (2) is attachable to said access device (1) and slidable oversaid dilator (480).

Example 39. A transapical access system for creating a transapicalpassage on a beating heart, said system including an access device (1)for a heart according to any of originally filed claims 1 to 21, and/or

an applicator tool (4) for creating a transapical passage and deliveringsaid access device (1) to an apex of said heart according to any ofexamples 31 to 38.

40. The system of example 39, comprising a fixture template (190) fortargeted puncture of said apex.

41. The system of example 40, wherein said fixture (190) has a patientspecific shape for said apex, such as selected from multiple fixtures ormanufactured based on imaging data of said apex.

Example 42. A method of creating a transapical passage on a beatingheart, said method including

determining a position on an apex region for creating a transapicalpassage

creating a transapical hole at said determined apex region throughcardiac muscle tissue,

delivering an access device having a through port to said transapicalhole,

attaching a flange unit of said access device to said heart, and

removably connecting a hemostatic valve unit to said access device.

43. The method of example 42, including arranging a plurality of suturesat said transapical hole for said attaching said flange unit of saidaccess device to said heart.

44. The method of any of examples 42 to 43, including cutting saidcardiac tissue at said apex with a sharpened edge at a distal end of atube.

45. The method of any of examples 42 to 44, including preventingwithdrawal of a harpoon through said cardiac tissue by expanding aflange of said harpoon.

46. The method of any of examples 42 or 43, including creating saidtransapical hole with an applicator tool including penetrating cardiactissue at said apex with a distal tip of a harpoon member through atube.

47. The method of any of examples 45 or 46, including keeping said cutcardiac tissue within said tube by said expanded flange of said harpoonmember.

48. The method of any of examples 42 to 47, including indicatingpenetration of said cardiac tissue into an interior of said heart with ablood indicator at distal end of a tube of an applicator tool being influid communication with a proximal seal including a blood indicator.

49. The method of example 42 or 43, including creating said transapicalpassage with an applicator tool including penetrating cardiac tissue atan apex with a penetration needle of said applicator tool insertablethrough a co-axial dilator having a distal tip dilating said cardiactissue.

50. The method of example 49, including arranging a tubular through portof said access device across said cardiac tissue when advanced over saiddilator.

51. The method of example 50, including removably attaching a removablehemostatic valve unit to said access device and sliding said removablehemostatic valve unit over said dilator.

52. The method of any of examples 42 to 51, including

transapically passing a driving rod of a cardiac assist unit into saidheart through said hemostatic valve;

attaching a sealing unit to said access device through said hemostaticvalve unit and over said driving rod;

sealing said transapical passage through said access device by saidsealing unit;

removing said hemostatic valve unit from said access device;

53. The method of example 52 including said

removing said hemostatic valve unit from said access device by

disconnecting said hemostatic valve unit from said access device andwithdrawing said hemostatic valve unit out of the patient, or

splitting or partitioning said hemostatic valve unit.

54. The method of any of examples 42 to 53, including deploying anannuloplasty chain ring at a cardiac valve annulus.

55. The method of any of examples 42 to 54, including removing adelivery tube out of patient and sealing against blood leakage from saidheart by a hemostatic valve unit.

56. The method of any of examples 42 to 54, wherein said applicator toolis the applicator tool of any of examples 22 to 29, said access deviceis the access device of any of originally filed claims 1 to 21, and/orsaid hemostatic valve is that of any of claims 22 to 26.

Example 57. A method of transapically implanting a medical device on abeating heart including

removably attaching said medical device to a sealed access device (1)affixed to said heart.

58. The method of example 57, said access device having a sealed tubularthrough port adapted to be arranged across cardiac tissue to a heartchamber,

and a flange unit sealingly affixing said access device to said heart.

59. The method of any of examples 57 to 58, including attaching asealing unit to said access device for creating a separation of a wetzone and a dry zone inside a mammal body.

60. The method of any of examples 57 to 59, including inserting adelivery tube through a hemostatic valve attached to said access device.

61. The method of any of examples 57 to 60, including attaching saidmedical device to said sealed access device while a hemostatic valve anda sealing unit are attached to said access device, and detaching saidhemostatic valve by splitting or peeling-off said hemostatic valve.

62. The method of any of examples 57 to 61, wherein said medical deviceis removably attached to said sealed access device.

63. The method of any of examples 57 to 62, wherein said medical deviceis comprised in a cardiac assist system.

64. The method of any of examples 57 to 63, wherein said access deviceis the access device of any of claims 1 to 21, and/or said hemostaticvalve is that of any of claims 21 to 26.

65. A method of accessing a heart of a patient comprising:

accessing said heart of said patient;

accessing a heart chamber of said heart;

securing a base plate at an apex region of said heart and extending tosaid heart chamber;

associating a sealing unit with said base plate and thereby creating adry zone isolated from said heart chamber;

It should be noted that the skilled person will understand that some ofthe devices disclosed herein in combination with other devices can beprovided and implemented as standalone devices, independent of the otherdevices or combined systems and methods described herein. An example isthe access device 1, which can be provided as an access port to theinner of the heart for other applications than described herein. Anotherexample is the application tool 4 that may be provided to safelypuncture a tissue wall and provide the tissue wall with a tissuepassage. Also, the removable hemostatic valve 2 may be provided forattachment to other units than an access device 1.

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this invention belongs. It will befurther understood that terms, such as those defined in commonly useddictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of the relevant art andwill not be interpreted in an idealized or overly formal sense unlessexpressly so defined herein.

The present invention has been described above with reference tospecific embodiments. However, other embodiments than the abovedescribed are equally possible within the scope of the invention, whichis only limited by the appended patent claims.

LIST OF REFERENCE SIGNS

-   -   1 access device for a heart        -   100 apical base plate        -   110 connection interface        -   115 locking unit        -   120 tubular through port        -   125 sealing surface for sealing unit 3        -   130 sealing surface for hemostatic valve 2        -   150, 151 mounting spikes        -   155 bayonet joint        -   160 flange unit        -   165 sutures        -   170 suture hole        -   190 template for positioning an access device        -   191 cut-outs of template        -   192 cut-outs for suture stitching    -   2 hemostatic valve unit (inflatable valve assembly)        -   200 housing        -   202, 204 splittable housing parts        -   210 inflation port        -   220 inflatable balloon member        -   222 balloon lobe        -   225 valve through port        -   230 sealing surface for sealing against access device 1        -   250, 251 Mounting apertures (mating with 150,151)        -   255 bayonet pins for joint 155        -   260 sealing element    -   3 sealing unit (bellows assembly)        -   310 bellows        -   320 feed-through port        -   325 first sealing member for sealing against access device        -   326 second sealing member for sealing feed through port        -   330 detaining unit        -   340 magnetic coupling    -   4 applicator tool for creating a transapical passage (apex punch        assembly)        -   400 pistol grip        -   410 tube        -   412 sharp tip of tube        -   415 trigger for pushing tube 410 forward        -   417 claw        -   420 control dial for rotating tube        -   450 harpoon        -   455 proximal end of harpoon 450/rod 470        -   460 penetration needle        -   461 seat        -   465 needle trigger        -   466 needle spring        -   467 safety pin        -   470 rod        -   471 shoulder        -   472 head (distal end portion) of rod with retaining unit        -   473 retaining unit e.g. barb, hook or fluke or wire mesh        -   474 moveable and lockable stop element        -   475 tissue plug        -   480 dilator        -   490 penetration/blood indicator    -   5 transapical access system    -   6 drive unit for cardiac assist        -   610 driving rod        -   620 sensor        -   630 electrical connection        -   650 anchor unit/annuloplasty implant    -   7 delivery system        -   70 delivery tube        -   72 inserter unit        -   74 pusher    -   700 a method of creating a transapical passage on a beating        heart        -   710-730 method steps    -   800 a method of transapically implanting a cardiac assist system        -   810 method step    -   10 heart        -   12 apex region of heart 10        -   14 outside of heart        -   15 inside of heart        -   20 heart chamber        -   30 Wet zone        -   32 Dry zone

1. An access device for a heart chamber comprising: an apical baseplate; a sealing unit associated with the base plate; a channelextending through the apical base plate when the sealing unit ispositioned in the base plate; and, the channel sized and shaped toremovably receive at least a portion of a cardiac assist unit.
 2. Theaccess device of claim 1, wherein the sealing unit extends into theheart chamber when the sealing unit is positioned in the base plate. 3.The access device of claim 1 wherein the sealing unit includes afeed-through port aligned with the channel.
 4. The access device ofclaim 1, wherein the sealing unit has a seal mechanism in the feedthrough port.
 5. The access device of claim 1, wherein said sealing unitincludes a magnetic coupling.
 6. The access device of claim 1, whereinthe cardiac assist unit includes a drive unit attachable to the apicalbase plate.
 7. An implantable cardiac assist system comprising: anaccess device for attachment to an external surface of a heart; theaccess device having a through-port providing access to an interior of aheart when attached to the external surface of a heart; a cardiac assistunit sized for placement in the through-port such that at least aportion of the cardiac assist unit extends to the interior of a heart;and, the cardiac assist unit sized for creating a seal in thethrough-port.
 8. The implantable cardiac assist system of claim 7,wherein said cardiac assist unit comprises a drive unit.
 9. Theimplantable cardiac assist system of claim 7, wherein the through-portincludes a sealing element.
 10. The implantable cardiac assist system ofclaim 7, wherein the cardiac assist unit includes a connection interfaceto engage with the access device.
 11. The implantable cardiac system ofclaim 7, wherein the access device includes an implantable apical baseplate.
 12. The implantable cardiac system of claim 7, wherein the apicalbase plate comprises a flange.
 13. The implantable cardiac system ofclaim 7, wherein the through port comprises a tube extending into theheart.
 14. A device for accessing a heart chamber comprising: a baseplate attachable to an apex of a heart; a sealing unit associated withthe base plate; a channel extending through the base plate when thesealing unit is positioned in the base plate; and, the channel sized andshaped to removably receive at least a portion of a cardiac assist unit.15. The device of claim 14, wherein the sealing unit extends into theheart chamber when the sealing unit is positioned in the base plate. 16.The device of claim 14 wherein the sealing unit includes a feed-throughport aligned with the channel.
 17. The device of claim 14, wherein thesealing unit has a seal mechanism in the feed through port.
 18. Theaccess device of claim 14, wherein said sealing unit includes a magneticcoupling.
 19. The device of claim 14, wherein the cardiac assist unitincludes a drive unit attachable to the base plate.
 20. The device ofclaim 14, wherein the base plate is an apical base plate.